Tegaserod, an investigational serotonin receptor agonist, provides global relief of the symptoms of constipation-predominant irritable bowel syndrome (IBS) with an acceptable incidence of adverse events, according to the results of meta-analysis of four phase III trials presented at Digestive Disease Week in San Francisco.
FDA actions in Brief
Pipeline Preview as reported July 1, 2002
New Indications: First approval of oral treatment for postherpetic neuralgia
NME: Option for life-threatening fungal infections
NME: Approved for all symptomatic stages of pulmonary arterial hypertension
New labeling for the cholesterol-loweringagent simvastatin (Zocor, Merck) highlights the risks of myopathyand rhabdomyolysis with or without acute renal failure as side effectsof the drug alone or in combination.
Confusion between two drugs with sound-alike proprietary names, the antipsychotic quetiapine fumarate (Seroquel, AstraZeneca) and antidepressant nefazodone HCl (Serzone, Bristol-Meyers Squibb) has prompted AstraZeneca to send a "Dear Healthcare Professional" letter warning of the potential mix-up.
Cases of uterine sarcoma in women receiving tamoxifen citrate (Nolvadex, AstraZeneca) have prompted a "Dear Health Professional" letter, black-box warnings on labeling, and publication of a letter to the editor in the New England Journal of Medicine from FDA officials.
A black-boxwarning added to baclofen's (Lioresal Intrathecal, Med-tronic) labelingwarns against abrupt discontinuation of the drug.
Safety information from the Celecoxib Long-term Arthritis Safety Study (CLASS)on GI and cardiovascular events has been included in safety labeling forcelecoxib (Celebrex, Searle).
Ever since troglitazone was pulled from the market because of hepatotoxicity,clinicians has been concerned that this may be a class effect. But a newstudy of rosiglitazone (Avandia), funded by manufacturer SmithKlineBeecham,indicates this drug is not associated with heptatotoxic effects.
Previous observational studies found that starting statins early after an MI reduces the risk of second heart attacks and death. But a new, larger observational study published last month in JAMA found no such reduction with early initiation (< 7 days)-and even an increased risk of MI or death for patients whose cholesterol levels were below treatment guideline levels.
The evidence doesn't support a link between administration of hepatitis B (HPB) vaccine and demyelinating disorders, such as multiple sclerosis (MS) and Guillain-Barré syndrome, so no change in immunization policy is warranted, according to an Institute of Medicine (IOM) report.
Eplerenone, a selective aldosterone inhibitor in phase III clinical trials,is an effective agent for reducing blood pressure in a variety of patientswith hypertension, including African-Americans, said presenters at the 17thannual scientific meeting of the American Society of Hypertension in NewYork City.
Switching from traditional nonsteroidal anti-inflammatory drugs (NSAIDs) to COX-2 selective drugs does not result in a decrease in gastrointestinal (GI) medical cotherapy. Furthermore, there is no reduction in GI healthcare costs when patients are switched from NSAIDs to selective COX-2 inhibitors, said Loren Laine, MD, at Digestive Disease Week in San Francisco.
Administrative databases are a potentially useful source of data for conducting retrospective studies. Information in such a database can be used to evaluate the effects of organizational policy changes, new programs, or pharmaceutical therapies. This month?s column reviews the six essential steps required for conducting a simple database analysis. An example involving sepsis is used to further illustrate key points.
Alefacept (Amevive) is the first immunosuppressive agent directed specifically at inhibiting the activation of, and possibly killing, T cells, which are involved in the cascade of events leading to psoriatic plaque formation and inflammation. In May, an FDA advisory committee recommended alefacept for approval as a first-line therapy against moderate to severe plaque psoriasis. The authors of this Focus article review the clinical characteristics of alefacept as well as make comparisons with other systemic drugs currently used to treat chronic psoriasis and the likely biologic competitors etanercept and infliximab.
The evidence supporting a role for the angiotensin II receptor blockers (ARBs) in patients with nephropathy and/or heart failure continues to evolve. Currently, the FDA is in late-stage review of the first ARB for a heart failure indication and is reviewing another ARB for a diabetic nephropathy indication. The authors of this article present and interpret the clinical evidence for ARB use in these two disease states. Included in their discussion are the most recent recommendations on ARBs’ place in therapy according to the American Diabetes Association, the American College of Cardiology, and the American Heart Association.
Anoka Regional Treatment Facility, Anoka, MN-This 150-bed regional treatment facility was spending over half its annual budget on atypical antipsychotic medications. In an effort to better control rising drug class costs, a market share shift analysis of the products currently in use at the facility was conducted.
Addendum questionnaire to June Focus On: Tadalafil
Addendum to June Focus On: Tadalafil
The investigational inhaled insulin product (Exubera) could prove a boon to patients with diabetes, cutting or eliminating the need for injections. So indicate findings from a phase III trial presented at the annual meeting of the American Association of Clinical Endocrinologists (AACE). For patients with type 1 diabetes, a regimen of inhaled insulin before meals and one injection at night could control blood glucose as well as or possibly better than injections alone. These results add to some phase III data presented last June that showed a small but significant number of patients with type 2 diabetes reached recommended blood glucose levels at 6 months.
FDA actions in Brief as reported June 1, 2002
The House leadership succeeded in toting up just enough votes in late June to approve a Medicare reform bill that provides some coverage of pharmaceuticals for seniors.
as reported June 1, 2002
